Study of Selumetinib (AZD6244)(ARRY-142886) in Combination With Irinotecan in Previously Treated Patients With Colorec
- Registration Number
- NCT01116271
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to determine whether treatment with Selumetinib (AZD6244) (Hyd-Sulfate) in combination with Irinotecan as a second treatment in patients with K-ras or B-raf mutation will prevent tumor progression and prolong progression free survival.
- Detailed Description
A Dose Finding and Phase II Study of Selumetinib (AZD6244) (Hyd-Sulfate) in Combination with Irinotecan, in 2nd Line Patients with K-ras or B-raf Mutation Positive Advanced or Metastatic Colorectal Cancer
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- Histological or cytological confirmation of advanced or metastatic colorectal cancer with available tissue and tumor sample confirmed as K-ras or B-raf mutation positive. Current failure of 1st line anti-cancer therapy with an oxaliplatin and bevacizumab based regimen or patients relapsing within 12 months of completing adjuvant FOLFOX .
Exclusion Criteria
- Treatment within 14 days prior to first study treatment with conventional therapy or treatment within 28 days prior to first study treatment with an investigational drug Prior treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen Prior treatment with a MEK or B-raf inhibitor or any irinotecan-containing regimen
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Irinotecan Selumetinib (AZD6244) in combination with irinotecan 1 AZD6244 Selumetinib (AZD6244) in combination with irinotecan
- Primary Outcome Measures
Name Time Method Dose Finding will be calculated based upon toxicity screening and dose modification guidelines within protocol. AEs will be assessed at each cycle visit, discontinuation treatment visit, and 30 days post last day of study treatment Objective Response Rate will be assessed by the RECIST guideline documented in the European Journal of Cancer, 2009. Tumor evaluation via RECIST guidelines will be done on screening visit, day 22 of every other cycle, and treatment discontinuation visit
- Secondary Outcome Measures
Name Time Method Safety of combination of Selumetinib (AZD6244) with irinotecan by SAE and AE documentation AEs will be assesed at the screening visit, each cycle visit, treatment discontinuation date, and 30 days post last day of study treatment PK of Selumetinib (AZD6244), N-desmethyl Selumetinib(AZD6244) and selumetinib (AZD6244) amide in combination with irinotecan PK sample draws will take place on Day 1 and 15 of first cycle Progression Free Survival (PFS) for patients with K-ras or B-raf mutations treated with combination of irinotecan and Selumetinib (AZD6244) PFS will be determined via the RECIST guidelines on tumor measurement done on day 22 of every other cycle and on the treatment discontinuation visit
Trial Locations
- Locations (2)
Reserach Site
🇺🇸Chapel Hill, North Carolina, United States
Research Site
🇺🇸Seattle, Washington, United States